|
ADASUVE(loxapine)inhalation powder
ADASUVE(loxapine)inhalation powder, for oral inhalation use
ADASUVE Rx
Generic Name and Formulations:
Loxapine 10mg; powder for oral inhalation.
Company:
Galen US Inc.
Indications for ADASUVE:
Acute treatment of agitation associated with bipolar I disorder in adults. Limitations of use: must be administered only in an enrolled healthcare facility.
Adult:
10mg by oral inhalation using a single-use inhaler. Administer only a single dose within a 24 hour period. Prior to administration, screen for current diagnosis or history of asthma, COPD, other lung diseases, and examine for respiratory signs. Monitor for signs/symptoms of bronchospasm and perform a physical exam at least every 15 mins for at least one hour after administration.
Children:
Not established.
Contraindications:
Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm. Acute respiratory signs/symptoms (eg, wheezing). Concomitant drugs to treat airways disease (eg, asthma, COPD). History of bronchospasm after Adasuve treatment. Amoxapine sensitivity.
Boxed Warning:
Bronchospasm. Increased mortality in elderly patients with dementia-related psychosis.
Warnings/Precautions:
Risk of bronchospasm. Administer only by a healthcare personnel in facility that has immediate access to manage acute bronchospasm. Increased mortality in elderly patients with dementia-related psychosis (not approved use). Monitor for neuroleptic malignant syndrome. Cardio- or cerebrovascular disease. Conditions that predispose to hypotension (eg, dehydration, hypovolemia, or concomitant antihypertensive drugs). Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester of pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Pharmacological Class:
Dibenzoxazepine.
Interactions:
Additive effects with concomitant other anticholinergics (eg, antiparkinson drugs) or other CNS depressants (eg, alcohol, opioids, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants); consider reducing dose of these drugs.
Adverse Reactions:
Dysgeusia, sedation, throat irritation; hypotension, syncope, lowered seizure threshold, anticholinergics effects (eg, glaucoma, urinary retention).
Note:
Available only through a restricted program under Adasuve REMS. Call (888) 970-7367 or visit www.adasuverems.com to enroll.
REMS:
YES
Generic Availability:
NO
How Supplied:
Single-use, disposable inhaler—5
ADASUVE(loxapine) inhalation powder, for oral inhalation use
INDICATIONS AND USAGE
ADASUVE®(loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.
Limitations of Use: As part of the ADASUVE Risk eva luation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM and
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Bronchospasm
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services. Facilities must have a short-acting bronchodilator (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.
Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk eva luation and Mitigation Strategy (REMS) called the ADASUVE REMS.
Increased Mortality in Elderly Patients With Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE is contraindicated in patients with the following:
Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm
Acute respiratory signs/symptoms (eg, wheezing)
Current use of medications to treat airways disease, such as asthma or COPD
History of bronchospasm following ADASUVE treatment
Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral loxapine and amoxapine
ADASUVE must be administered only by a healthcare professional
Prior to administration, all patients must be screened for a history of pulmonary disease and examined (including chest auscultation) for respiratory abnormalities (eg, wheezing)
Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the single-use inhaler
After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at least every 15 minutes for at least 1 hour
ADASUVE can cause sedation, which can mask the symptoms of bronchospasm
Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
ADASUVE may increase the risk of falls, which could cause fractures or other injuries. Patients taking antipsychotics with certain health conditions or those on long-term therapy should be eva luated by their healthcare professional for the potential risk of falls
Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine, and can also occur in epileptic patients
Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills
The potential for cognitive and motor impairment is increased when ADASUVE is administered concurrently with other CNS depressants
Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
Use of ADASUVE may exacerbate glaucoma or cause urinary retention
The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation
Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother
The safety and effectiveness of ADASUVE in pediatric patients have not been established。
https://www.adasuverems.com/AdasuveUI/rems/pdf/PrescribingInformation.pdf |
|
